Thoracic Surgery by SHURUI Single-Port Surgical Robot

Официальное название

Thoracic Surgery by SHURUI Single-Port Surgical Robot: A Prospective Single Centre Study

Обзор

The introduction of single-port surgical robot has been a transformative breakthrough in the medical field, representing a significant advancement in minimally invasive procedures. One notable innovation is the SHURUI single-port surgical robot (SP), developed by Beijing Surgerii Robotics Company Limited. The SHURUI SP represents a cutting-edge technology in the field. This system features snake-like surgical instruments utilizing "dual continuum mechanism", which enables precise single-port procedures with wide range of motion and high load capacity. The SHURUI SP has been cleared by the National Medical Products Administration (NMPA) of China for use in urology and gynecology and has completed clinical trials for general surgery and thoracic surgery. It is China's first and the world's second approved single-port surgical robot. Compared to multi-port surgical robots, it can provide patients with less trauma, fewer complications, and faster recovery. The SHURUI SP has also achieved significant breakthroughs in clinical applications. It conducted the world's first randomized controlled clinical trial on single-port robotic urologic surgery and introduced a series of innovative surgical paradigms. These include the world's first single-port sleeve lobectomy, single-port retroperitoneal adrenalectomy, single-port retroperitoneal partial nephrectomy, single-port distal gastrectomy (Billroth I anastomosis), and single-port total gastrectomy. Our centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, investigators have established our centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures. In this study, investigators evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by SHURUI SP.

Вмешательства

• Устройство Device: Endoscopic Surgical System, SR-ENS-600
  undergoing robotic thoracic surgery by the Endoscopic Surgical System, SR-ENS-600

Первичные конечные точки

• conversion rate [Срок оценки: 1 year + 1 month follow-up]
• major peri-operative complication rate (Clavein-Dindo grading III or above) [Срок оценки: 1 year + 1 month follow-up]

Вторичные конечные точки (11)

• Operation time [Срок оценки: 1 year]
• Estimated intraoperative blood loss (EBL) [Срок оценки: 1 year]
• Length of hospital stay [Срок оценки: 1 year + 1 month follow-up]
• Postoperative pain score [Срок оценки: 1 year + 1 month follow-up]
• Blood transfusion rate [Срок оценки: 1 year]
• The Surgeon Satisfaction Questionnaire [Срок оценки: 1 year+ 1 month follow-up]
• Perioperative complication [Срок оценки: 1 year]
• device defects incidence [Срок оценки: 1 year]
• readmission rate within 30 days after surgery [Срок оценки: 1 month follow-up]
• re-operation rate with 30 days after surgery [Срок оценки: 1 month follow-up]
• Mortality within 30 days after surgery [Срок оценки: 1 month follow-up]

Критерии участия

Критерии включения

• Age between 18 - 75 years;
• Subjects need to undergo endoscopic surgery and meet one of the following indications for surgical treatment:

• Lobectomy, segmentectomy wedge resection of lung: Clinically diagnosed resectable early stage non-small cell lung carcinoma; oligometastatic cancer to the lung;
• Mediastinal mass resection: Clinically diagnosed mediastinal tumour (benign or malignant) that are indicated for resection;
• Preoperative ASA grade: Grade I-III;
• Subject voluntarily participates in the clinical trial, and agrees or his/her guardian agrees and signs the informed consent.

Критерии исключения

• Subjects with a previous history of thoracic surgery or other malignant tumor which, in the judgement of the investigator, make them unsuitable for enrolment;
• Subjects with severe co-morbidities or organ dysfunction (heart, lung, liver, brain, kidney, etc.) or deemed too weak/ unsuitable for general anesthesia or operation;
• Non-correctable coagulopathy and severe bleeding tendency；
• Emergency surgery;
• Severe obesity with BMI ≥30 kg/m2;
• Subjects with severe allergic constitution, suspected or confirmed alcohol, drug addiction;
• Other circumstances in which the investigator considered participation in this clinical trial inappropriate.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Shatin

Идентификаторы

NCT: NCT07255703 · KF-600-3-583

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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